AzureDelta Consulting Inc.’s Post

📢News in oncology! The FDA has granted accelerated approval to repotrectinib, a multi-kinase inhibitor, for patients with solid tumours with NTRK gene rearrangement who are ineligible for surgery and have received prior therapy. This decision is based on the TRIDENT-1 clinical trial, showing an overall response rate of 50-58% in different patient subgroups. While further data is needed to confirm the clinical benefit, this marks a significant advancement. Read more here: https://lnkd.in/eCWMQ_hV In other news, the FDA has approved durvalumab in combination with carboplatin and paclitaxel followed by durvalumab maintenance for women with advanced or recurrent dMMR endometrial cancer. The DUO-E clinical trial demonstrated a substantial PFS improvement, especially in patients with dMMR tumours. This aligns with findings from a recent meta-analysis confirming the PFS benefit of adding immunotherapy to chemotherapy in this patient population. Read more here: https://lnkd.in/dJdTSfPX 📰Stay tuned for more updates by subscribing to our newsletter! https://lnkd.in/dZD5n5Rm #FDAApproval #ClinicalTrials #Oncology #CancerResearch #Trialing

"Pharmacists say testing patients for DPYD gene variants before starting fluoropyrimidine chemotherapy is the right thing to do — even though U.S. clinical practice guidelines don't yet recommend the practice." Pre-treatment DPYD testing is standard practice in Europe but not in the United States, despite calls for it to become so. While guidelines continue to lag behind, hospitals and cancer centers nationwide are implementing DPYD testing into their standard of care. Read more from ASHP about the facilities and organizations paving the way for making #DPYD testing the norm for ensuring safer cancer treatment. https://lnkd.in/gDCDwWJn #pharmacogenomics #precisiononcology #precisionmedicine #cancertreatment #pgx

"Pharmacists say testing patients for DPYD gene variants before starting fluoropyrimidine chemotherapy is the right thing to do — even though U.S. clinical practice guidelines don't yet recommend the practice." Pre-treatment DPYD testing is standard practice in Europe but not in the United States, despite calls for it to become so. While guidelines continue to lag behind, hospitals and cancer centers nationwide are implementing DPYD testing into their standard of care. Read more from ASHP about the facilities and organizations paving the way for making #DPYD testing the norm for ensuring safer cancer treatment. https://lnkd.in/gDCDwWJn #pharmacogenomics #precisiononcology #precisionmedicine#cancertreatment #pgx

"Pharmacists say testing patients for DPYD gene variants before starting fluoropyrimidine chemotherapy is the right thing to do — even though U.S. clinical practice guidelines don't yet recommend the practice." Pre-treatment DPYD testing is standard practice in Europe but not in the United States, despite calls for it to become so. While guidelines continue to lag behind, hospitals and cancer centers nationwide are implementing DPYD testing into their standard of care. Read more from ASHP about the facilities and organizations paving the way for making #DPYD testing the norm for ensuring safer cancer treatment. https://lnkd.in/gDCDwWJn #pharmacogenomics #precisiononcology #precisionmedicine #cancertreatment #pgx

Something to be watching for in the Gene and Cell Therapy space. The FDA announced yesterday that they were investigating serious risk following CAR-T Therapy Per the FDA statement- "Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action." Gene and Cell Therapy continues to be an area where we are still learning what we don't know yet! https://lnkd.in/gNwW57mC #GeneTherapy #celltherapy #cellandgenetherapy #Pharmacists #pharmacybenefits #oncology Innovative Rx Strategies

📰 FDA grants accelerated approval to repotrectinib for adult and pediatric patients with NTRK gene fusion-positive solid tumors 🎯🧬 Efficacy Results:  📊 ORR in TKI-naïve group: 58% (95% CI: 41, 73); ORR in TKI-pretreated group: 50% (95% CI: 35, 65) ⏱ Median DOR: Not Estimable (NE) in TKI-naïve group; 9.9 months (95% CI: 7.4, 13.0) in TKI-pretreated group Concarlo Therapeutics is especially proud of our Chief Development Officer, who launched Turning Point Therapeutics' Repotrectinib global project team (Phase 1b/2a) and led nonclinical development during pre-submission phase of this important drug. Our commitment to serving patients with cancer continues to drive us towards innovative solutions in precision medicine, specifically as we explore p27 modulators as novel therapeutic strategies for CDK inhibitor-resistant cancers. https://lnkd.in/eCWMQ_hV #CancerResearch #Oncology #FDAApproval #PrecisionOncology #ConcarloTherapeutics #biomarker #InnovativeMedicine #PatientCare #ClinicalDevelopment

Exploration of Targeted Anti-tumor Therapy | Open Exploration ⏰ It's time to Explore the mysteries of tumor therapy with us! 😆 Contact us to discuss your exciting ideas: [email protected] 🔎 Tips! Welcome to your submission (Indexed in #PubMed/Scopus and #GoogleScholar with no Article Processing Charges) 💡 【Exciting New #CaseReport Alert! 】 🎬 Improving single nucleotide polymorphisms genotyping accuracy for dihydropyrimidine dehydrogenase testing in pharmacogenetics 📖 This case study underscores the critical importance of considering alternative genotyping approaches, such as WGS, when conventional techniques represent challenges. 👨⚕️ Authors: Annalaura Montella, Sueva Cantalupo, @Giuseppe D’Alterio, Vincenzo Damiano, Achille Iolascon, Mario Capasso* 📚 This article belongs to the special issue Molecular Diagnosis and Personalized Therapy of Cancer #Pharmacogenetics, #dihydropyrimidine #dehydrogenase, #genotyping 🏃♂️ Let's stay informed in the world of cancer therapeutics! https://lnkd.in/gdZ_mxMb

Our collaborative effort uncovering in vivo vulnerabilities to #GPX4 and #HDAC inhibitors in drug-tolerant versus drug-resistant #BRAF V600E lung adenocarcinoma is out in #CellRepMed. Led by Marie-Julie Nokin, David Santamaria, & Chiara Ambrogio. 🔬  Whole-genome CRISPR screening and RNA sequencing identified ferroptosis as drug-tolerant persister (DTP) vulnerability in BRAF V600E LUAD. 💊 Persister cells suffered from lipid peroxidation and were sensitive to ferroptosis upon GPX4 inhibition in vivo. 🔬 Acquired alterations leading to mitogen-activated protein kinase (MAPK) reactivation enhanced cystine transport to boost GPX4-independent antioxidant responses (sensitized tumors to HDAC inhibition). https://lnkd.in/ed64wH4p Dana-Farber Cancer Institute, Università degli Studi di Torino, University of #Bordeaux

A trio of updates in the last 24 hours on some closely-watched clinical trials: 1) Verve Therapeutics is halting enrollment in a phase 1 study testing VERVE-101 after two grade 3 AEs were reported in a patient. The biotech is now prioritizing its second PCSK9 editor, VERVE-102. Story: https://lnkd.in/dmXAqiWi 2) Gritstone bio failed a phase 2 study testing its cancer vaccine, acknowledging that the change in circulating tumor DNA was likely the wrong endpoint to measure. The company is pointing to PFS data as a sign of encouragement. Story: https://lnkd.in/drcSikPZ 3) Roivant Sciences and Matthew Gline are giddy once again, thanks to phase 2 data of brepocitinib in patients with active non-infectious uveitis. The treatment failure rates at both treatment doses exceeded the primary endpoint, where a lower rate indicates better efficacy. Story: https://lnkd.in/d5jmzPve

#FDAapproved #newdrug (afamitresgene autoleucel (Tecelra, Adaptimmune Therapeutics), on 8/2/2024, for the treatment of unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen. Prior to treatment biomarker tests are required that will detect human leukocyte antigens type and melanoma-associated antigen A4 tumor expression. A test from Agilent Technologies was also approved today that will identify these biomarkers. Thermo Fisher’s SeCoreTM CDx HLA-A Locus Sequencing System can also be used. Afamitresgene autoleucel was approved with a boxed warning for Cytokine Release Syndrome. Afamitresgene autoleucel was approved based on results from the 52 patient cohort 1 of the open-label, Phase II, SPEARHEAD-1 trial, where treatment with a single dose of afamitresgene autoleucel resulted in an overall response rate of 37% in patients with HLA-A*02 and MAGE-A4-expressing advanced synovial sarcoma or myxoid round cell liposarcoma. (Lancet. 2024 Apr 13;403(10435):1460-1471) Adaptimmune Therapeutics set WAC at $727,000 for the one-time treatment with afamitresgene autoleucel. #prescriberight #pharmacists #physicians #nurses